Aceclofenac (Siclofen) 100 mg

Pronunciation

• a-se-KLO-fen-ak

Trade Name

• Siclofen

Classification

• Therapeutic: Anti-inflammatory
• Pharmacologic: Nonsteroidal anti-inflammatory drug (NSAID)

Pregnancy Category

• Category C (D in the third trimester)

Indications

• Relief of pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
• Used to treat other acute pain conditions.

Mechanism of Action

• Aceclofenac works by inhibiting the enzyme cyclooxygenase (COX), which is involved in the synthesis of prostaglandins. Prostaglandins are mediators of inflammation, pain, and fever. By reducing their production, aceclofenac decreases inflammation and alleviates pain.

Pharmacokinetics

• Absorption: Well absorbed after oral administration; peak plasma concentrations are reached in about 1-3 hours.
• Distribution: Widely distributed throughout the body; highly protein-bound (~99%).
• Metabolism: Metabolized primarily in the liver to the main metabolite, 4'-hydroxyaceclofenac.
• Excretion: Excreted mainly in the urine as metabolites; small amounts are excreted in the feces.
• Half-life: Approximately 4-4.5 hours.

Contraindications and Precautions

• Contraindications: Hypersensitivity to aceclofenac or any other NSAIDs, history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; active gastrointestinal bleeding or ulceration; severe renal or hepatic impairment.
• Precautions: Use with caution in patients with a history of gastrointestinal disorders, cardiovascular disease, hypertension, renal or hepatic impairment, and in elderly patients. Prolonged use can increase the risk of cardiovascular events and gastrointestinal bleeding.

Adverse Reactions and Side Effects

• Common: Dyspepsia, nausea, diarrhea, abdominal pain, dizziness, headache.
• Serious: Gastrointestinal bleeding, ulceration, perforation, hypersensitivity reactions (e.g., anaphylaxis), renal impairment, liver dysfunction, cardiovascular events (e.g., myocardial infarction, stroke).

Interactions

• Drug-Drug: May increase the risk of bleeding when taken with anticoagulants or other NSAIDs; can reduce the effectiveness of antihypertensives; may increase the plasma levels of methotrexate and lithium.
• Food: Taking aceclofenac with food can decrease gastrointestinal side effects.

Route/Dosage

• Oral (Tablets):
  • Adults: The usual dose is 100 mg twice daily, taken with or after food.
  • Pediatric Dosage: Not typically recommended for children.

Availability Formulations

• Siclofen Tablets: Available in packs containing 30 tablets of 100 mg each.